Pilot Clinical Study of the LRS ThermoSuit™ System in Post Arrest Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-09-30

Brief Summary

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The purpose of this study is to determine if the Life Recovery Systems Thermosuit(R) System is able to quickly and conveniently cool patients who are comatose after resuscitation from cardiac arrest.

Detailed Description

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The primary purpose of this study is to clinically evaluate the use of a new cooling device (the LRS ThermoSuit(R) System) to cool patients who are comatose following resuscitation from cardiac arrest. This device cools by circulating cold water directly against the skin of the patient. Cooling to a state of mild hypothermia (32 to 34 degrees C, maintained for 12 to 24 hours) is recognized by the American Heart Association, European Resuscitation Council, and the Canadian Association of Emergency Care Physicians as a promising therapy for such patients, and is likely to be most effective if administered quickly following resuscitation. It is hypothesized that this new device will cool patients much more quickly than by historical means. Patients will be monitored for physiologic parameters such as body temperature during the cooling therapy, and will be tracked for neurological outcomes following treatment.

Conditions

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Heart Arrest Coma

Keywords

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resuscitation hypothermia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ThermoSuit(R) System

The LRS ThermoSuit System is used to cool patients using direct contact of the skin with cold water.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Cardiac arrest prior to or during hospital admission, with restoration/return of spontaneous circulation (ROSC).
* Cardiac arrest of presumed cardiac origin.
* Initial (pre-resuscitation) cardiac rhythm of ventricular fibrillation, non-perfusing ventricular tachycardia, pulseless electrical activity, or asystole.
* Estimated or known age \> 18 years.
* Intubation, ventilation and placement of esophageal probe.
* Estimated time from collapse to the initiation of Advanced Cardiac Life Support (ACLS) \< 15 minutes and return of spontaneous circulation with defibrillation within 60 minutes of collapse.
* Persistent neurologic dysfunction i.e. comatose upon enrollment \[GCS ≤ 8\].

Exclusion Criteria

* Height greater than 188 cm.
* Elbow-to-elbow width greater than 60 cm (as measured above the supine patient).
* Core temperature less than 34°C after ROSC (as measured at the tympanic membrane, esophagus, sub-lingual space, nasopharynx, or central blood vessel).
* Comatose state before the cardiac arrest due to the administration of drugs that depress the central nervous system.
* Known pregnancy.
* Response to verbal commands after ROSC (but before enrollment).
* Known terminal illness that preceded the arrest.
* Known enrollment in another study of a device, drug, or biologic.
* Major trauma or other co-morbidity requiring urgent surgery.
* Improving neurologic status.
* \> 8 hours since return of spontaneous circulation.
* Unknown time of arrest.
* Severe or known coagulopathy (with active bleeding).
* Hemodynamic instability despite vasopressors (SBP \< 90 mmHg or MAP \< 60 mmHg for \> 30 minutes after ROSC and before enrollment).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Livfe Recovery Systems

Principal Investigators

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Dorian Paul, MD

Role: PRINCIPAL_INVESTIGATOR

St. Michael's Hospital, University of Toronto

Daniel Howes, M.D.

Role: PRINCIPAL_INVESTIGATOR

Kingston Health Sciences Centre

Locations

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Kingston General Hospital

Kingston, Ontario, Canada

Site Status

St. Michael's Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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LRS-01-05-02

Identifier Type: -

Identifier Source: org_study_id